Senior Specialist, Quality Assurance
3 weeks ago
Job Summary
Cardinal Health is seeking a Senior Specialist, Quality Assurance to join our team. This role will be responsible for ensuring the quality of our products and services, as well as developing and implementing quality policies, procedures, and processes.
Key Responsibilities
- Develop and implement quality policies, procedures, and processes to ensure compliance with regulatory standards and specifications.
- Conduct cGMP documentation reviews related to product release, facilities, and equipment.
- Establish and report metrics related to products and processes.
- Ensure the site manufactures products to meet the requirements of 21 CFR 212 (cGMP).
- Handle and ensure quality of documentation to support cGMP activities.
- Collaborate with operations department to drive quality system and cGMP requirements.
- Perform product release activities per cGMP requirements.
- Report quality system issues to the Regional Quality Manager and others as necessary.
Requirements
- Bachelor's degree in a related field (science) preferred, or equivalent work experience.
- 2+ years of experience in a related science field preferred.
- 1-2 years of experience in Quality Assurance and/or cGMP regulated environment highly preferred.
- Pharmaceutical or medical device experience a plus.
- Effective written and verbal English communication skills.
- ISO experience a plus.
- Ability to lift up to 30-45 lbs.
Work Environment
The primary work environment consists of a manufacturing pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition.
Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards.
The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group.
Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation.
Noise levels are considered low to moderate.
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